Schizophrenia, Psychosis
Conditions
Keywords
cognition, pshysical activity, metabolic syndrome
Brief summary
Tracking down the efficacy of a combined intervention of cognitive remediation (CR) and phisycal activity (aerobic exercise, AE) in patients diagnosed with schizophrenia
Detailed description
The investigators will address the following objectives: * Primary objective: o assess, through a randomized controlled trial (RCT), the efficacy and feasibility of a combined intervention (CR + AE) in patients with schizophrenia. The primary outcome measure will be cognitive performance, while secondary outcomes will include scales for the assessment of psychopathology, daily functioning, and quality of life. * Secondary objectives: to evaluate changes in bio-physical and laboratory metabolic parameters, as well as in neurotrophic and neuroinflammatory factors. Furthermore, multimodal magnetic resonance imaging (MRI) parameters will be evaluated after the interventions, and their relationship with observed cognitive improvements will be explored.
Interventions
BEHAVIORALCognitive Remediation (CR)
The CR consists of three 1-hour sessions per week of domain-specific computerized exercises, for a period of 12 weeks, totaling 36 hours
BEHAVIORALAerobic Exercise
Aerobic exercise consists in two session per week of cycling. Each session lasts for 45 min, with 15 min of warm up pre and post session
OTHERCognitve Remediation + Aerobic Exercise
Patients performed both CR exercises and cycling
Sponsors
IRCCS San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
All patients will be randomized in a 1:1:1 ratio to three parallel treatment arms: experimental intervention (CR + AE) and two active comparison arms (CR and AE)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients diagnosed with Schizophrenia 2. Age 18-65 years 3. Psychopathological stability 4. Ability to provide informed consent
Exclusion criteria
1. Comorbidity with intellectual disability and neurological disorders. 2. Ongoing treatment with CR or AE. 3. Specific contraindications for AE.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive performance | 7 months | Cognition is assessed through the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB): a neuropsychological battery developed for the assessment of the main cognitive domains impaired in schizophrenia. Range T-values: 20-80. Higher values mean a better score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psychopathology assessment | 7 months | Psychopathology is assessed trough the scale Positive and Negative Syndrome Scale (PANSS). Values range 1-7, higher scores mean worse functioning |
| Quality of Life assessment | 7 months | Quality of life is assessed through the scale Quality of Life Scale (QLS). Values range 0-6. Higher values mean better functioning |
| Daily functioning assessment | 7 months | daily functioning is assessed through the task UCSD Performance-based skill assessment (UPSA-B). Values range 0-1. 1 means better functioning |
| Blood pressure | 7 months | Systolic and diastolic blood pressure (mm Hg) are assessed for the evaluation of metabolic syndrome and physical fitness |
| Diffusion Tensor Imaging (DTI) | 4 months | DTI was performed to assess the integrity of brain white matter and to estimate the axonal organization of the brain. Its unit of measure is µm²/ms |
| Waist circumference | 7 months | Waist circumference (cm) is assessed for the evaluation of physical fitness |
| Metabolic indices | 7 months | Tryglicerides, HDL cholesterol and fasting plasma glucose are assessed through blood sampling. All of them are measured in mg/dL |
| Body Mass Index (BMI) | 7 months | Physical fitness is assessed through the evaluation of BMI (kg/m\^2) |
Countries
Italy
Outcome results
None listed